Geropharm is seeking a compulsory license for an expensive drug for the treatment of spinal muscular atrophy

On May 14, the Moscow Arbitration Court will consider the claim of the pharmaceutical company Geropharm against the Swiss Roche and the US PTC Therapeutics for granting a compulsory license for a drug for the treatment of spinal muscular atrophy (SMA) risdiplam.

Risdiplam is protected by a patent in Russia until 2036. Geropharm has not yet registered an analog of risdiplam; no information has been found about clinical trials and trials of the generic drug. 

Geropharm could have used Article 1362 of the Civil Code of the Russian Federation, which allows it to apply to the court for a compulsory license on the grounds that the patented invention has not been used or underused for 4 years from the date of patent issuance, suggests Sergey Zuykov, managing partner of Zuykov and partners. According to him, an appeal to the court is possible after the patent owner refused to conclude a license agreement with the applicant.

A Roche representative claims that the company has received a request from Geropharm for a voluntary license and promised to respond within the prescribed time frame. But Geropharm went to court without waiting for an answer. Probably, Geropharm hopes to prove the insufficiency of drug supplies to the Russian market, suggests Sergey Zuykov. He draws attention to the fact that the drug is practically unavailable in retail. According to AptekaMos reference information, risdiplam is available in Moscow in two pharmacies at a price starting from 795,000 rubles for the packaging.

The second option for obtaining a compulsory license is that Geropharm has dependent patents (for "modified" inventions) from the Roche patent for risdiplam, Zuykov points out. Then the Russian company will have to prove to the court that its invention represents an important technical achievement and has significant economic advantages over Roche's invention.

Source: Vedomosti